PROJECTSUMMARY TheDataManagementandAnalysisCore(CoreC)willinteractimportantlywitheachofthe4projects, andtheScientificCoreB.Wehavedevelopedadetailedplantooptimizethesynergyandinteractionsamong theprojects,coresandpersonnelinvolvedinthestudiesproposedinthisU19applicationforacoordinated dataanalysisstrategy.Notably,themembersofeachoftheProjectsandCoresarealreadyinteracting scientifically,andhavepublishedtogetherinallergyresearch.Accordingly,shouldthisrenewalapplicationbe funded,theproposedworktoadvanceourunderstandingofthepathologyofhumanfoodallergy,andthe mechanismsthatcontributetotherapeuticresponsestooralimmunotherapywithmultiplefoodallergens(multi- OIT)withorwithoutthebiologictherapeuticsomalizumabordupilumab(theCOMBINEtrial)willrepresenta continuationandexpansionoftheseongoingcollaborativeefforts. TheDataManagementandAnalysisCorehasthreeSpecificAims: Aim1:Providedataanalysisandstatisticalsupportforthepilotphase2clinicaltrialofProject1,evaluating whethertreatmentwithmulti-OITcombinedwitheitheromalizumabordupilumabvs.multi-OITaloneresultsin ahigherproportionofparticipantsbeingabletopassafoodchallengeatweek24(primaryendpoint)andafter aperiodofwithdrawalatweek30(asecondaryendpoint)inmulti-foodallergicpatientstreatedwithmulti-OIT, andalsoanalyzingongoingsafetydatacollectedinthecourseofthetrial. Aim2:Provideintegratedandcoordinatedstatisticalanalysisoftheclinicalandimmunologicalassaydata thatwillbecollectedbyProjects1,2,3and4,andtheScientificCoreB,toattempttoidentifyimmune systemfeaturesthatarepredictiveofwhetherornotmulti-foodallergicparticipantswillachieve desensitization,orpotentiallysustainedunresponsivenessaftermulti-OIT,andtoattempttoidentifyimmune systemfeaturesthatcanbeusedtoidentifyindividualsatincreasedriskofexperiencingadversereactionsto OIT.Wewillalsoanalyzelong-termfollowupspecimensfromourpriorongoingPOISEDandcompleted MAPXtrials,toassesswhethertherearecorrelationsbetweenimmunologicalassayresultsandlong-term clinicaloutcomes. Aim3:WorkwithProject1andScientificCoreBtobuildandmaintaindatabasesorganizingtheclinical andlaboratorydataobtainedinProjects1,2,3and4andCoreB,tofacilitatesharingandanalysisofdata fromtheCOMBINEtrialandprojects,andalsofromlongtermfollow-upstudiesofparticipantsinourPOISED andMAPXtrials.